Device Classification Name |
Folders And Injectors, Intraocular Lens (Iol)
|
510(k) Number |
K112977 |
Device Name |
MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4) |
Applicant |
ALCON RESEARCH, LTD. |
6201 SOUTH FREEWAY |
FORT WORTH,
TX
76134 -2099
|
|
Applicant Contact |
Catherine Goble |
Correspondent |
ALCON RESEARCH, LTD. |
6201 SOUTH FREEWAY |
FORT WORTH,
TX
76134 -2099
|
|
Correspondent Contact |
Catherine Goble |
Regulation Number | 886.4300
|
Classification Product Code |
|
Date Received | 10/06/2011 |
Decision Date | 03/27/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|